Awareness of the Convention on Biological Diversity (CBD)

This overview is intended to build awareness of the Convention on Biological Diversity and associated collections stewardship considerations.

The United Nations Convention on Biological Diversity (CBD) is an international treaty that came into force on 29 December 1993. The CBD makes clear the fundamental concept of “biodiversity” falling under the “sovereign rights” of each country as agreed at the UN in 1962. Thus, each nation is responsible for managing its own biodiversity. It introduced the concept of fair and equitable sharing of benefits arising from the use of genetic resources; the key rationale if this was to emphasize the intrinsic value stream associated with exploitation of biodiversity and hence the need for biodiversity conservation to remain a sustainable resource. Users of biological resources are now responsible for complying with regulations on biodiversity use at the national and/or regional levels (see section V below). These regulations differ between countries and may be constantly changing. These frequent changes and their implications for ownership rights have created an exceptional level of uncertainty for biological research and development, as well as the role and responsibilities of natural history collections.

The CBD has three main objectives:

The conservation of biological diversity

The sustainable use of components of biological diversity

The fair and equitable sharing of benefits arising from the utilization of genetic resources (this objective is also called ABS)

The conservation and sustainable use objectives of the CBD are based on having sound information and science. In addition to sharing information on genetic resources available for research using an access and benefit sharing framework, GGBN Member institutions work within many science programs spread across the world either directly or indirectly by supplying information on protected areas and ecosystems and possible threats to them.

However, implementing an ABS regime on biodiversity has turned out to be exceedingly difficult due to the many people representing widely different objectives. Uncertainties range from an unclear definition of what “access” means in context of the Nagoya Protocol (see below) to what constitutes sharing of “benefits arising from the utilization of genetic resources.” This has hampered harmonisation tremendously, which, at least temporarily, has made collection and movement of genetic resources more difficult and uncertain.

In addition, there is added complexity to the ABS obligation which stems from an extension of benefit sharing to encompass utilization of traditional knowledge, innovations and practices relevant for the sustainable use and conservation of biological diversity (often referred to as TK). The TK discourse is sometimes intermixed with the genetic resources discussions, but we will keep them separate as they are affecting different processes within countries and internationally (with many of the TK discussions now occurring in the World Intellectual Property Organization [WIPO]). However, GGBN Member institutions should pay attention to TK in the context of ABS and utilization of Genetic Resources. Note that the Nagoya Protocol covers Traditional Knowledge associated with Genetic Resources (aTK) rather than TK on its own.

The Nagoya Protocol and Access and Benefit Sharing

The Nagoya Protocol on access to genetic resources and fair and equitable sharing of benefits arising from their utilization entered into force on 12 October, 2014. It is an international agreement adopted under the Convention on Biological Diversity (CBD). The Nagoya Protocol provides a guideline for the effective implementation of the third objective of the CBD.

GGBN is following discussions on the Nagoya Protocol carefully to make sure that GGBN and its Members can fulfil any obligations which might arise from those discussions. Not all countries have ratified the Nagoya Protocol, but researchers from countries that have done so will need to be compliant with national regulations.

Many countries have developed or are in the process of developing appropriate laws and regulations to manage their sovereign rights over their genetic resources. GGBN expects that researchers working on behalf of GGBN Member institutions follow national laws wherever they work. The regulations of provider countries may carry obligations that apply after samples have left the country, such as restrictions on use, third party transfer, and tracking of any shared benefits. These obligations place demands on a GGBN Members’ internal documentation of compliance, data, and research procedures.

Prior Informed Consent (PIC)

Prior informed consent (PIC) is a permission given by the Competent National Authority of a country to an individual researcher or institution seeking to obtain access to genetic resources and/or TK, complying with an appropriate legal and institutional framework (CBD Secretariat Information Kit). It covers what is collected and how, the expected uses of the collected material, and any emergent conditions that may require re-negotiation of the existing PIC. Consequently, in seeking PIC you must provide a full explanation of these elements.

Mutually Agreed Terms (MAT)

Mutually agreed terms (MAT) is an agreement between provider country/provider of genetic resources (and traditional knowledge) and the users, on the conditions of access and utilization of the resources, and on the benefits to be shared between both parties (CBD Secretariat Information Kit). This might address issues such as restrictions of use, third party transfer, reporting requirements, data sharing and/or other benefit sharing. Change of use etc. may require re-negotiation.

Benefit-sharing

Benefits can be both economic and non-economic, including academic, such as joint research and training. Benefits range from direct payments to knowledge attained. The Nagoya Protocol has an annex with a list of possible monetary and non-monetary benefits, which might be listed in a MAT (see below). Having materials in GGBN Member collections provides long-term security that there will be access to the materials under the conditions originally agreed or new agreed conditions with the provider country.

Traditional Knowledge

Traditional Knowledge can be found in a wide variety of contexts. It is knowledge resulting from intellectual activity in a traditional framework that is specific or general in its relationship to the genetic resources. It includes know-how, practices, skills, and innovations. As knowledge is shared locally, finding the right people to have PIC and MAT discussions with is not always clear. Multiple claims on the same knowledge across different communities further complicate this approach. Note that the Nagoya Protocol explicitly covers Traditional Knowledge Associated with Genetic Resources.

Monetary and Non-monetary Benefits

Monetary and Non-monetary benefits, as outlined by the Annex of the Nagoya Protocol

Monetary benefits may include, but not be limited to:

(a) Access fees/fee per sample collected or otherwise acquired;

(b) Up-front payments;

(c) Milestone payments;

(d) Payment of royalties;

(e) License fees in case of commercialization;

(f) Special fees to be paid to trust funds supporting conservation and sustainable use of biodiversity;

(g) Salaries and preferential terms where mutually agreed;

(h) Research funding;

(i) Joint ventures;

(j) Joint ownership of relevant intellectual property rights.

Non-monetary benefits may include, but not be limited to:

(a) Sharing of research and development results;

(b) Collaboration, cooperation and contribution in scientific research and development programs, particularly biotechnological research activities, in the Party providing genetic resources;

(c) Participation in product development;

(d) Collaboration, cooperation and contribution in education and training;

(f) Transfer to the provider of the genetic resources of knowledge and technology under fair and most favourable terms, including on concessional and preferential terms where agreed, in particular, knowledge and technology that make use of genetic resources, including biotechnology, or that are relevant to the conservation and sustainable utilization of biological diversity;

(g) Strengthening capacities for technology transfer;

(h) Institutional capacity-building;

(i) Human and material resources to strengthen the capacities for the administration and enforcement of access regulations;

(j) Training related to genetic resources with the full participation of countries providing genetic resources, and where possible, in such countries;

(k) Access to scientific information relevant to conservation and sustainable use of biological diversity, including biological inventories and taxonomic studies;

(l) Contributions to the local economy;

(m) Research directed towards priority needs, such as health and food security, taking into account domestic uses of genetic resources in the Party providing genetic resources;

(n) Institutional and professional relationships that can arise from an access and benefit- sharing agreement and subsequent collaborative activities;

(o) Food and livelihood security benefits;

(p) Social recognition;

(q) Joint ownership of relevant intellectual property rights.

GGBN’s role

Open access to biodiversity research data and corresponding specimens in repositories is vital for basic, non-commercial biological science and essential to support the objectives of the CBD. GGBN Member institutions commit themselves to acquiring, using and managing genetic resources in compliance with international conventions and national laws and regulations. Accordingly, GGBN has developed Material Transfer Agreements, Code of Conduct, and Best Practice guidance documents for Members’ use. It is recommended that GGBN Members provide information on the provenance of samples when providing or transferring material (this may be required under national law, as in all EU Member States). Downstream monitoring and tracking of utilised genetic resources is a recognized challenge that must be met. In response to this challenge, GGBN has developed a permit vocabulary as part of the GGBN Data Standard that helps to standardize the tracking of permit information associated with genetic resource records across GGBN Member institutions and beyond. By 2020 it is mandatory that all GGBN Member institutions providing data to the GGBN Data Portal link associated information on permits and compliance agreements to specimens collected on or after 12 October 2014.

Next Steps

GGBN task forces are currently working to identify ways to trace information on usage of genetic resources within and beyond the network, such as

exploring ways to ensure that unique permit identifiers and ABS documents are associated with both original and descendent samples (e.g. individuals taken from a multi-specimen lot, tissues taken from specimens, DNA extracted from tissues).

exploring how to create durable links between the identifier and the permits and other ABS documents.

exploring the use of physical tags that can be placed on specimens with the identifier of the permit and ABS agreements (e.g. test string or QR code) and mutually agreed terms (e.g., “no 3rd party transfer”, or “do not sequence”).

proposing the GGBN data standard as the global standard for implementing the Nagoya Protocol across all portals and to ensure that all relevant portals are cross-linking permit information. Targeted portals include BOLD, INSDC, and GBIF.

Resources to assist compliance with the Nagoya Protocol

Note that some of these documents will soon be superseded by newer versions; please be aware of the effective dates associated with each document/resource.

Example for linking permit and other rights information to specimen records using an Enterprise-level data management system, see frequently asked questions, number eight, below (please note that this is a work in progress, developed by the National Museum of Natural History, Smithsonian Institution).

Other Codes of Conduct, Best Practices, and learning tools

Access and Benefit Sharing Information Forum (note that this is a work in progress, developed by Natural History Museum London, Royal Botanic Gardens Kew and Royal Botanic Gardens Edinburgh): http://nagoyaprotocol.myspecies.info/

Answers to Frequently Asked Questions (FAQ) on ABS

1. What is the ABS clearing house?

The Access and Benefit-Sharing Clearing-House (ABSCH) is a platform for exchanging information on ABS (incl. Country specific information for Parties) and a key tool for facilitating the implementation of the Nagoya Protocol. https://absch.cbd.int/

2. My country hasn’t signed or ratified the Nagoya Protocol yet. Does it affect my field work and associated research?

It is recommended that the user follow the legislation or regulatory measures of the provider country. This is usually done by negotiating prior informed consent (PIC) and mutually agreed terms (MAT), when required. Understanding these concepts will greatly assist in making sure you have all of the appropriate paperwork and permissions to do the research you intend to do.

The impact on a user from a non-party country may come if there is a research partner working in a country that is a party to the Nagoya Protocol, as the research partner may have to implement requirements of his or her domestic legislation.

3. What steps do I have to take if I want to collect samples?

Obtain PIC (if required) and establish MAT if required by national law of the country where you are collecting (e.g. PIC might be granted by the national or state government or by local communities, MAT might be negotiated with the relevant government contact or with communities or scientific partners). The providing country's Competent National Authority (CNA) will issue a permit or its equivalent to the user, or may issue evidence that the user obtained PIC as required (e.g. from local communities). (Note: other non-ABS permits may still be necessary!). Any collection permits etc. might need to be secured as usual.

National ABS Focal points for both parties and non-parties to the Nagoya Protocol can be contacted for help with obtaining collecting permits. Focal points for each country can be found on the ABS Clearing-House at https://absch.cbd.int/search/nationalRecords?schema=focalPoint. Note that not all countries have a focal point in place!

It must be noted that this applies to collecting samples in any country, not just parties to the Nagoya Protocol.

4. In which ways does the GGBN support GGBN Members with ABS compliance?

GGBN supports GGBN Members with ABS compliance by providing access to available resources, tools and use cases. Gaps in these resources are monitored, assessed, and filled as needed by the Policies task force. See sections III, GGBN’s Role, and IV, Available Resources to Assist Compliance with the Nagoya Protocol, above.

5. What is the difference between the three GGBN Material Transfer Agreements? How do I know which one to use?

A single MTA would not cover all requirements. For outgoing material, the requirements for temporary transfer of material (loans) and permanent transfer are very different.

Temporary transfer/loan refers to material where there is no change of ownership in the transaction.

Permanent transfer refers to material where there is a change in ownership, the new owner taking on the rights and responsibilities attached on the material.

In addition to MTAs covering outgoing material, it was decided that one covering incoming material would be useful. As a result, the following MTAs were developed for both Member and non-Member use:

Note that not all countries have a focal point in place! Note also that the Focal Points only have responsibility for providing information about ABS permits and agreements; countries may have other permit requirements for which that Focal Point cannot provide advice.

If you a consult a Focal Point, make sure to document the conversation and link this information to the specimen records within your data management system as permit information.

7. How should researchers deal with situations where there is no way to get a legal permit? What are GGBN’s recommended guidelines for due diligence?

If you cannot get a proper permit, you should not engage in the activity. For some countries, obtaining a written communication is almost impossible. It is recommended that researchers look to the focal points listed in the ABS Clearing-House for guidance. If you cannot find a contact in the ABS Clearing-House, then contact the ABS Clearing-House directly.

Make records of your attempts to get a permit. It may be helpful to the overall permitting process and function of a country’s clearinghouse to have feedback about the challenges of gaining permits and other aspects of compliance.

8. Are there countries which have a single point of contact for permitting? If so, how do I access this information?

Note that the ABS Focal Point has responsibility for ABS information only. There may be other permit requirements in a country (e.g. for collecting in protected areas, for working with indigenous people, etc.) as well as export permits and research permits. The ABS Focal Point may be unaware of these, and they may be handled by different government departments. The majority of countries do not have a single information point.

9. How do I get PIC and MAT for biodiversity inventories (where I don’t know in advance what species will be sampled)?

Each country develops PIC and MAT based on their unique laws and regulations. As a result, PIC and MAT for biodiversity inventories must be negotiated with the provider country. We recommend the national focal point as the best place to start with this request. This also applies to permitting.

10. Are collections from private land exempt from Nagoya?

No. It is necessary to document permissions given to the collector from the private land owner in a formal letter or e-mail correspondence. This information should be linked to the specimen records as permit information. However, obtaining permission to collect from private land does not make PIC and MAT with the provider country superfluous.

11. How should museums and other genetic collections holding institutions handle specimens acquired without an MTA (e.g., a fish that came from Brazil through an aquarium shop)?

In this example, the MTA serves to transfer rights and obligations to the collection. Even if it is only transfer of title (as might be expected in the example), there should be some documentation to show that the specimen is in the custody of the collection and that the specimen was legally acquired in the first place. In general, organizations should not accept material without clarity on their obligations and rights regarding incoming collections. In the example, the specimen was exported from a country for the pet trade, a different use from scientific research. Before accepting it for the collection, the collection should seek PIC from the country (if the country is known and has access legislation) to allow change of use. In this particular case e.g., Brazil would claim sovereign rights over the genetic heritage embodied in the fish.

12. What should be done with samples obtained after October 12, 2014 for which documentation cannot be obtained? Should they be kept or deaccessioned?

Samples for which documentation cannot be obtained should be returned to the provider. If the provider is unknown, it is up to the individual institution to decide, based on their policy, whether or not to deaccession the material. Please note that this is relevant only to material accession since the Nagoya Protocol went into force on October 12 2014 and only for parties to the Nagoya Protocol.

13. What do we do with collections collected before 12 October 2014?

When documenting collections, all permit and other rights (e.g. deed of gift, MTA, PIC, MAT) information should be recorded and directly associated to the specimens in the database of record or data management system. This is highly recommended for all collections, but only required as part of GGBN’s Data Standard for those collections collected on or after 12 October 2014.

Note that irrespective of the Nagoya Protocol there may be permits (i.e. contracts with the providing country) dating from before October 2014, and these are still valid.

In an effort to clearly demonstrate that your collections were acquired legally and are used according to the terms under which they were acquired, we recommend that all permit and other rights information (e.g. deed of gift, MTA, PIC, MAT) be recorded and directly associated to the specimens in the database of record or data management system.

For an example of recording rights information in an enterprise level system, such as EMu (working version courtesy of the National Museum of Natural History, Smithsonian Institution), see: https://library.ggbn.org/share/s/GdifJFHuRFm7zC01pWxydg. For an example working list of agreement names used for tracking permit and other rights information in EMu see: https://library.ggbn.org/share/s/7FyPCtMiRDiOPLOipSXqKQ. Agreements within these categories are linked to the sample record within the museum’s database of record (i.e. EMu) and mapped to the GGBN Data Standard’s permit fields.

GGBN is currently exploring methods for more rigorous tracking of permit information (e.g. at the collections database level) and will share use case information with the GGBN community as it becomes available.

15. Is it possible to flag genetic sample records published on GGBN that are not associated with permit data, specifically those collected after the implementation of Nagoya?

Yes. The GGBN Data Standard allows individual institutions to flag sample records not associated with permit data and set those records “not to publish” or “blocked” within their database of record or data management system.

16. Are biodiversity biobanks third party sites? Are scientists, who collected samples with appropriate documentation to collect, able to pass the samples to the biodiversity biobank? What if the biodiversity biobank is the scientist’s home institution?

This depends on the requirements in the PIC and MAT. Ideally the permission to pass material to a biobank should be negotiated. Because the users of a biobank are third parties, this should also be agreed in PIC and MAT. Note that some permits do not allow sequencing, which would mean that the material should not be placed in a biobank.

17. How should collections track and trace downstream products (sampling/sequencing/publishing)?

No current solution exists for the rigorous tracking and tracing of downstream products. It is the responsibility of the user to report publications or other research products to the provider if required per MTAs. It is recommended that permit or other rights information be included in academic publications or associated with other research products (e.g. sequence information published on GenBank). This requirement may be outlined by the provider in a MTA.

18. Are there any mechanisms in place for monitoring whether genetic resources have been utilized with prior informed consent and mutually agreed terms?

Within Parties to the Nagoya Protocol the named checkpoints (e.g. patent offices, research funding agencies) are responsible for submitting Checkpoint Communiques to the ABS Clearing-House with information about utilization of genetic resources from Parties that are reported according to provisions laid down in the user country legislation. Such reports will include identifiers of any Internationally Recognized Certificates of Compliance (IRCC) or permits so the provider country can know what is being utilized. Provider countries would receive alerts that a Communique about their genetic resource has been posted, and it would then be up to the provider to check compliance with PIC and MAT.

Note that IRCCs are already being issued and most permits have a number associated with them.

19. Who is obligated to participate in compliance with Nagoya?

Only parties of the Nagoya Protocol are obligated to participate in compliance measures, such as appointing a checkpoint. Only a few countries to date have a named checkpoint.

20. Would the GGBN be suited to develop standardized and harmonized procedures for international transfer of tissue and DNA samples-comparable to IPEN?

Yes. This is an option that GGBN is currently exploring.

21. Does Nagoya change any existing agreements that are already in place between users and providers?

No. These are made subject to national laws and procedures; Nagoya has no effect on their content.

22. Does Nagoya ease use of collections for commercial purposes?

Only insofar as provider countries may have more confidence that compliance in the user country will be monitored and any legal recourse facilitated. Commercialization should be addressed in PIC and MAT.

23. Does benefit sharing apply only where there is a move to commercialize a genetic resource collected under a permit?

No. Benefit-sharing includes non-monetary benefits and can be a significant element of non-commercial agreements.